Zydus Cadila seeks DCGI nod for clinical trials of monoclonal antibodies cocktail that neutralises COVID infection

Speaking on the development, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Ltd., said, "At this juncture, there is a critical need to explore safer and more efficacious treatments to combat COVID. It is important to look at different stages of the disease progression and look at options that can reduce patient's suffering and discomfort. We believe that ZRC-3308 has the potential to address these concerns and provide a safe treatment."

Recently, the US FDA withdrew the emergency use authorization of a mAb product after new variants emerged in the country that were not being neutralized by the product.

ZRC-3308 is a cocktail of two monoclonal antibodies targeting two unique epitopes on the spike protein of SARS-CoV-2. The monoclonal antibodies of ZRC-3308 have been specifically designed to provide protection for a much longer period of time than the currently approved products. The enhanced design would also help in preventing any further tissue damage and thereby reducing the risk of severe disease.

ZRC-3308 has demonstrated the ability to neutralize SARS-CoV-2 both in vitro and in animal studies. In animal studies ZRC-3308 reduced damage to the lungs in both prophylactic and therapeutic settings. ZRC-3308 has been found to be safe and well tolerated in animal toxicology studies. Zydus is currently seeking permission to initiate phase 1/3 human clinical trials from the DCGI.